Bufferin Extra Strength FDA Alerts

Drug Safety Communication: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

Oct 15, 2020 | Audience: Consumer, Patient, Health Professional, Pharmacy

ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.

For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.

For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.

BACKGROUND:

NSAIDs

• are a class of medicines available by prescription and OTC. They are some of the most commonly used medicines for pain and fever.
• are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu.
• work by blocking the production of certain chemicals in the body that cause inflammation.
• are available alone and combined with other medicines. Examples of NSAIDs include aspirin, ibuprofen, naproxen, diclofenac, and celecoxib.

Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

RECOMMENDATION:

Consumers/Patients

• If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.
• Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels to find out if the medicines contain NSAIDs.
• Talk to your health care professional or pharmacist if you have questions or concerns about NSAIDs or which medicines contain them.
• Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. Talk to your pharmacist or health care professional for help deciding which might be best.

Health Care Professionals

• FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
• Oligohydramnios is often, but not always, reversible with treatment discontinuation.
• Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
• If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus.
• The above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy.
• Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice.

Consumers, patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

[10/15/2020] - Drug Safety Communication - FDA]

Source: FDA

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Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets

Jun 19, 2013 | Audience: Consumer, Pharmacy, Health Professional

ISSUE: Advance Pharmaceutical Inc. announced that this firm is conducting a voluntary nationwide recall to the user level of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually containing Acetaminophen 500 mg tablets. Consumers may be inadvertently taking Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day, or those who have liver disease. The labeled directions instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg). 

BACKGROUND:  The product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablet with NDC 0536-3086-41 and UPC 3 0536-3086-41 9. The affected lot of Enteric Coated Aspirin Tablets is Lot 13A026 with Expiration Date 01-2015. The lot was manufactured and packaged by Advance Pharmaceutical Inc. under the label of Rugby Laboratories. Rugby Laboratories (Major Pharmaceuticals) distributed the product nationwide to wholesalers and retailers. Advance Pharmaceutical Inc. notified Rugby Laboratories of the recall by e-mail and overnight mail, and is arranging for return of all recalled bottles. 

RECOMMENDATION: Consumers who have the affected lot should immediately discontinue its use and return it to the pharmacy or store where it was purchased. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Any adverse reactions experienced with the use of this product should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

 

[06/19/2013 - Firm Press Release - Advance Pharmaceutical Inc.]

[06/19/2013 - Photo - Product Label]

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Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

Jan 9, 2012 | Audience: Consumer, Pharmacy

ISSUE: Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter products Exedrin, Bufferin, Gas-X Prevention and NoDoz. Reports were received of chipped and broken pills and inconsistent bottle packaging clearance practices at the Lincoln, Nebraska facility, which could result in the bottles containing foreign tablets, caplets, or capsules.

Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.

BACKGROUND: This voluntary recall pertains to all lots of select bottle packaging configurations from retailers of Excedrin and Nodoz products (expiry dates of December 20, 2014 or earlier), and Bufferin and Gax-X Products (expiry dates of December 20, 2013 or earlier), in the United States.

RECOMMENDATION: All of the pills in the bottle should look the same. If patients find a pill that is different in shape, size, color, or markings, they should bring their medicine bottle to their pharmacist and not take any of those pills.

Consumers that have the product(s) being recalled should stop using them and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[01/08/2012 - Press Release - Novartis]

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Ibuprofen and Aspirin Taken Together

Sep 8, 2006 | Audience: Consumers and healthcare professionals[Posted 09/08/2006] FDA notified consumers and healthcare professionals that taking Ibuprofen for pain relief and aspirin at the same time may interfere with the benefits of aspirin taken for the heart. Ibuprofen can interfere with the anti-platelet effect of low dose aspirin (81 mg per day), that may render aspirin less effective when used for cardioprotection and stroke prevention. Although it is all right to use Ibuprofen and aspirin together, FDA recommends that consumers contact their healthcare professional for more information on the timing of when to take these two medicines, so that both medicines can be effective.

[September 8, 2006 - Healthcare Professional Sheet - FDA]
[September 8, 2006 - Drug Information Page - FDA]

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