Check Back or Hip Pain on Isotretinoin in Pakistan: DRAP Sacroiliitis Alert
DRAP Safety Alert 60 says isotretinoin acne medicine may be linked to sacroiliitis, pelvic joint inflammation. See the pain to report and what to do next.
Short answer: DRAP's Safety Alert No. 60 of 30 January 2026 says isotretinoin, the prescription acne medicine, may be linked to sacroiliitis, which is inflammation of the pelvic joints. If you take it and develop lasting lower back, hip or buttock pain, especially pain that is worse at night or at rest, tell your doctor. Do not stop the treatment without medical advice.
A student in Lahore starts a course of isotretinoin for severe acne and, a few months in, wakes at night with a dull ache low in the back. It is easy to blame the gym or the mattress. The alert asks patients and doctors to also think of the medicine.
We read the alert on DRAP's safety page on 12 October 2026. This article covers what DRAP says, which pain to report and what to do next.
DRAP warns of a possible link between isotretinoin and sacroiliitis
Sacroiliitis is inflammation of the sacroiliac joints, the two joints where the spine meets the pelvis. It usually shows up as pain. DRAP's alert says isotretinoin may be associated with it.
The alert is based on a March 2025 safety review by Health Canada. DRAP's expert committee discussed it on 31 December 2025. It decided that companies holding a registration for isotretinoin in Pakistan must add the risk of sacroiliitis to the Adverse Drug Reactions and the Warnings and Precautions sections of the label.
This is a warning and a labelling change. DRAP did not recall isotretinoin or restrict its sale in this alert.
What the Canadian review found, and what it could not explain
Health Canada looked at 24 cases from around the world. Of these, 23 were judged possibly linked to isotretinoin and 1 unlikely to be linked. The average age in cases that gave an age was 20 years. No deaths were reported.
| Finding in the alert | Detail |
|---|---|
| International cases reviewed | 24 |
| Possibly linked to isotretinoin | 23 |
| Unlikely to be linked | 1 |
| Average age, where given | 20 years |
| Deaths | None reported |
| Outcome | Improved after stopping isotretinoin and with treatment |
Health Canada also reviewed 18 published articles. They supported a link but did not find a clear biological reason for it. So the evidence is a pattern, not a proven mechanism. The alert gives no figure for Pakistan.
Which pain should you report
DRAP's advice to patients is specific. Contact your doctor if you develop persistent lower back, hip or buttock pain, especially if the pain is worse at night or with rest. And do not stop treatment without medical advice.
Persistent means it does not go away in a few days. Many people get back pain from sitting or sport, which usually eases with movement. Pain that gets worse when you rest, or wakes you at night, is the pattern the alert names.
- Lower back pain that does not settle
- Pain in one or both hips or buttocks
- Pain that is worse at night or when resting
These are the signs to mention at your next appointment, or sooner if the pain is severe.
What to do if you take isotretinoin
Isotretinoin is a prescription drug for severe acne in patients aged 12 and over when other treatments fail. It is taken under a doctor's supervision with regular checks. The alert adds one more thing to watch.
- Confirm the medicine name on the strip or capsule box, isotretinoin, and note the start date.
- Tell the doctor about any back, hip or buttock pain that lasts, and say when it began.
- Say whether it is worse at night or at rest.
- Keep taking it as directed until the doctor tells you otherwise.
- Report the pain to DRAP so it can be counted.
Never buy isotretinoin without a prescription or from an unlicensed seller. A licensed pharmacy is the safe route, and DRAP's registration check confirms the product is registered.
Report it to DRAP through the e-form or the app
DRAP's National Pharmacovigilance Centre takes reports from patients and professionals through the Med Vigilance e-reporting system and the VigiMobile app. The centre's phone is 051 9255981 and its email is npc@dra.gov.pk.
The step by step guide is in how to report a medicine side effect to DRAP. Your report helps DRAP see whether Pakistani patients show the same pattern. If you suspect a fake, use the counterfeit medicine route instead.
Common questions
Has DRAP banned isotretinoin?
No. The alert is a safety warning and a label update. Isotretinoin stays available on prescription.
Is sacroiliitis permanent?
The alert says it improved after stopping isotretinoin and with appropriate treatment in the cases reviewed. It does not promise that for every patient.
Does isotretinoin always cause back pain?
No. The alert describes a possible link in a small number of reported cases. Most users will not have this problem.
Should I stop the capsules if my back hurts?
The alert says not to stop treatment without medical advice. Contact your doctor, who will decide.
Does it apply to acne creams?
The alert is about isotretinoin, the oral prescription medicine for severe acne. It does not discuss creams.
Where can I read the alert?
It is DRAP Safety Alert No. 60, listed under Safety Communication on the DRAP website and linked below.
How we verified this
What we checked, where we read it, and what we could not confirm.
We read DRAP Safety Alert No. 60 dated 30 January 2026 and DRAP's safety updates page on 12 October 2026. This is a summary of the alert and not medical advice.
About the author
Public Services and Education Journalist
Fajr Riaz is a journalist and content writer at Pakistan Era, based in Lahore. She covers the questions people meet in everyday life in Pakistan: how a public service works, what a change in the rules means, and where to find a reliable answer.
